REGULATORY FIRST
International regulator directory
These 18 official entry points cover China, North America, Europe, Asia-Pacific, Latin America, Africa and WHO. To check approval, labelling, safety or originator/generic status, first fix the market, product, dosage form, route and strength; the authority’s current page remains controlling.
Read: how reference, originator and generic records differ across markets →
OFFICIAL SOURCE
NMPA
China National Medical Products AdministrationMedicine regulation, review and public information
Open official page ↗OFFICIAL SOURCE
NMPA data search
China medicine-record queryCheck mainland China records against the latest approval document and label
Open official page ↗OFFICIAL SOURCE
CDE China Listed Drug Database
China reference preparations and standardsOfficial entry point for listed-drug, reference preparation and standard records
Open official page ↗OFFICIAL SOURCE
FDA
United States Food and Drug AdministrationApprovals, labels, drug safety and generic-medicine information
Open official page ↗OFFICIAL SOURCE
FDA Orange Book
United States reference and therapeutic-equivalence recordsCheck RLD, reference-standard, dosage-form, route and equivalence information under U.S. rules
Open official page ↗OFFICIAL SOURCE
EMA
European Medicines AgencyEuropean Union medicines, assessment reports and safety updates
Open official page ↗OFFICIAL SOURCE
MHRA
United Kingdom medicines regulatorUK medicine regulation and pharmacovigilance
Open official page ↗OFFICIAL SOURCE
PMDA
Japan Pharmaceuticals and Medical Devices AgencyJapanese medicine review and safety information
Open official page ↗OFFICIAL SOURCE
MFDS
Republic of Korea Ministry of Food and Drug SafetyMedicine safety and regulatory information
Open official page ↗OFFICIAL SOURCE
HSA
Singapore Health Sciences AuthorityMedicine registration and product-information entry point
Open official page ↗OFFICIAL SOURCE
TGA
Australia Therapeutic Goods AdministrationTherapeutic-product registration and safety information
Open official page ↗OFFICIAL SOURCE
Health Canada
Canada health-product regulatorDrug and health-product regulatory information
Open official page ↗OFFICIAL SOURCE
Anvisa
Brazil health surveillance agencyMedicine marketing-authorisation and regulatory information
Open official page ↗OFFICIAL SOURCE
SAHPRA
South Africa health-products regulatorRegistered medicines, pharmacovigilance and safety alerts
Open official page ↗OFFICIAL SOURCE
Swissmedic
Switzerland medicines regulatorMedicine authorisation, safety and official notices
Open official page ↗OFFICIAL SOURCE
Medsafe
New Zealand medicines safety authorityMedicine safety, product and regulatory information
Open official page ↗OFFICIAL SOURCE
CDSCO
India Central Drugs Standard Control OrganizationMedicine standards, authorisation and safety regulation
Open official page ↗OFFICIAL SOURCE
WHO
World Health OrganizationInternational standards, essential medicines and regulatory-system resources
Open official page ↗